Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer

NCT07841730 | Not Yet Recruiting

• 1 other identifier: DFU Early grades26
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.

Conditions

Diabetic Foot

Keywords

Tibial nerve mobilization; Multisensory Exercises; Diabetic foot ulcer; Diabetic Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  The Berg Balance Scale (BBS) is a commonly used clinical scale for assessing static and dynamic balance in sitting and standing. It consists of 14 functional balance items that assess the ability to maintain positions and perform postural adjustments during functional movements. Each item is scored from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance. The BBS has demonstrated high reliability and good validity for assessing balance.

  Baseline and immediately after 4 weeks of intervention

Secondary Outcomes (3)

• Short Form-12 Health Survey (SF-12)

  Baseline and immediately after 4 weeks of intervention

• SINBAD Scoring System:

  Baseline and immediately after 4 weeks of intervention

• Toronto Clinical Neuropathy Score (TCNS)

  Baseline and immediately after 4 weeks of intervention

Study Arms (2)

Tibial Nerve Mobilization

EXPERIMENTAL

Behavioral: Tibial Nerve Mobilization

Multisensory Exercises

ACTIVE COMPARATOR

Behavioral: Multisensory exercises

Interventions

Tibial Nerve Mobilization BEHAVIORAL

Participants will receive supervised physical therapy targeting neuropathic symptoms, healing , mobility issues, quality of life associated with diabetic foot ulcers early grades. The regimen consists of 35 to 45 -minute sessions, 3 days per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy, including Transcutaneous Electrical Nerve Stimulation (TENS).Pulse Duration: 150 µs and 80 Hz frequency for effective nerve stimulation and pain relief, active and passive ankle range-of-motion exercises, dosriflexion and plantar flexion, inversion eversion ,with 10 repetitions for10 minutes and foot care education which includes moisturizing and hygiene advice and foot wear guidance . This is followed by a 20-minute main intervention of tibial nerve mobilization, which utilizes a combination of remote sliders, local sliders, and tensioners (end-range neural loading) to promote neural sliding and elongation while minimizing mechanical stress.

Also known as: Nerve flossing, Neural Mobilization, Neural Gliding

Tibial Nerve Mobilization

Multisensory exercises BEHAVIORAL

Participants will receive a multisensory exercises training program alongside conventional physical therapy. The regimen consists of 35-to 45 minute sessions, 3 times per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy (TENS, ankle range of motion, and foot care). Exercises include a structured warm-up, ankle flexion ,extension, inversion , eversion , short walk ,calf and hamstring stretching 10 repetitions Followed by 20 minutes of multisensory training.Visual system activities (e.g., eye tracking ,follow moving object , circular eye movements and visual-motor coordination. Somatosensory exercises (walking on varying surfaces such as flat surface , mattresses and foam rubber). Proprioception/vestibular stimulation (e.g., unipedal stances, tandem stance , tandem walking( heel to toe walk), walking variations such as backward , forward, multidirectional walking, and cognitive dual-task obstacle navigation eg. functional mobility training .

Multisensory Exercises

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 55-75 years
• Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.
• Both male and female participants.
• Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.
• Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg/dl or Random Blood Glucose ≥ 200 mg/dl.
• Patient with healed ulcer or in last stage of healing duration \>1 to 2 weeks
• Absence of active infection.
• No cognitive impairments that would affect participation.
• Diabetes duration of less than 10 years.
• Able to perform the exercises and participate in physical therapy sessions.
• No history of amputation above the metatarsophalangeal joint.

You may not qualify if:

• Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
• Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
• Recent fractures, or trauma leading to nerve injuries in the last year.
• Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.
• Visual impairments or cognitive disorders that could affect participation.
• History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
• Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.
• Pregnancy or unwillingness to participate.

Sponsors & Collaborators

• University of Lahore: lead

Related Publications (20)

• Yang L, Rong GC, Wu QN. Diabetic foot ulcer: Challenges and future. World J Diabetes. 2022 Dec 15;13(12):1014-1034. doi: 10.4239/wjd.v13.i12.1014.

  PMID: 36578870 BACKGROUND

• Wang X, Yuan CX, Xu B, Yu Z. Diabetic foot ulcers: Classification, risk factors and management. World J Diabetes. 2022 Dec 15;13(12):1049-1065. doi: 10.4239/wjd.v13.i12.1049.

  PMID: 36578871 BACKGROUND

• Waghe VR, Athawale V. Physiotherapeutic Interventions in Diabetic Foot Ulcer Management: A Case Report. Cureus. 2024 Feb 29;16(2):e55244. doi: 10.7759/cureus.55244. eCollection 2024 Feb.

  PMID: 38558580 BACKGROUND

• Tran MM, Haley MN. Does exercise improve healing of diabetic foot ulcers? A systematic review. J Foot Ankle Res. 2021 Mar 20;14(1):19. doi: 10.1186/s13047-021-00456-w.

  PMID: 33743791 BACKGROUND

• Ramachandran V, Mohanasundaram T, Karunakaran D, Gunasekaran M, Tiwari R. Physiological and Pathophysiological Aspects of Diabetic Foot Ulcer and its Treatment Strategies. Curr Diabetes Rev. 2023;19(8):e031122210617. doi: 10.2174/1573399819666221103141715.

  PMID: 36330634 BACKGROUND

• McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care. 2023 Jan 1;46(1):209-221. doi: 10.2337/dci22-0043.

  PMID: 36548709 BACKGROUND

• Liu X, Ren Q, Zhai Y, Kong Y, Chen D, Chang B. Risk Factors for Multidrug-Resistant Organisms Infection in Diabetic Foot Ulcer. Infect Drug Resist. 2022 Apr 7;15:1627-1635. doi: 10.2147/IDR.S359157. eCollection 2022.

  PMID: 35418765 BACKGROUND

• Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.

  PMID: 40016658 BACKGROUND

• Idiaquez JF, Alcantara M, Bril V. Optimal cut-off value of the modified Toronto Clinical Neuropathy Score in the diagnosis of polyneuropathy. Eur J Neurol. 2023 Aug;30(8):2481-2487. doi: 10.1111/ene.15870. Epub 2023 May 30.

  PMID: 37203998 BACKGROUND

• Gupta G, Maiya GA, Bhat SN, Hande HM. Effect of Multifactorial Balance Rehabilitation Program on Risk of Falls and Functional Fitness in Older Adults with Diabetic Peripheral Neuropathy. Curr Aging Sci. 2023;16(3):240-247. doi: 10.2174/1874609816666230306150844.

  PMID: 37638589 BACKGROUND

• Goyat M, Saxena A, Goyal M. Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol". J Diabetes Metab Disord. 2022 Aug 15;21(2):2035-2041. doi: 10.1007/s40200-022-01106-z. eCollection 2022 Dec.

  PMID: 36404825 BACKGROUND

• Chatzinikolaou A, Tzikas S, Lavdaniti M. Assessment of Quality of Life in Patients With Cardiovascular Disease Using the SF-36, MacNew, and EQ-5D-5L Questionnaires. Cureus. 2021 Sep 14;13(9):e17982. doi: 10.7759/cureus.17982. eCollection 2021 Sep.

  PMID: 34667665 BACKGROUND

• Brocklehurst JD. The Validity and Reliability of the SINBAD Classification System for Diabetic Foot Ulcers. Adv Skin Wound Care. 2023 Nov 1;36(11):1-5. doi: 10.1097/ASW.0000000000000050.

  PMID: 37861669 BACKGROUND

• Aagaard TV, Moeini S, Skou ST, Madsen UR, Brorson S. Benefits and Harms of Exercise Therapy for Patients With Diabetic Foot Ulcers: A Systematic Review. Int J Low Extrem Wounds. 2022 Sep;21(3):219-233. doi: 10.1177/1534734620954066. Epub 2020 Sep 14.

  PMID: 32924691 BACKGROUND

• Aitken E, Hiew J, Hamilton EJ, Manning L, Ritter JC, Raby E, Gittings PM. Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety. J Foot Ankle Res. 2023 Mar 28;16(1):18. doi: 10.1186/s13047-023-00616-0.

  PMID: 36978157 BACKGROUND

• Akkus G, Sert M. Diabetic foot ulcers: A devastating complication of diabetes mellitus continues non-stop in spite of new medical treatment modalities. World J Diabetes. 2022 Dec 15;13(12):1106-1121. doi: 10.4239/wjd.v13.i12.1106.

  PMID: 36578865 BACKGROUND

• Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.

  PMID: 37395769 BACKGROUND

• Ashoori M, Hashemi SE, Pourahmadi M, Dadgoo M, Hosseini MS, Lotfi H, Ahmadi M. Adding tibial nerve neurodynamic techniques to a rehabilitative pain management strategy improved neuropathy severity and quality of life in patients with diabetic peripheral neuropathy: a randomized sham-controlled trial. BMC Complement Med Ther. 2025 Nov 24;25(1):429. doi: 10.1186/s12906-025-05168-3.

  PMID: 41286909 BACKGROUND

• Azharuddin M, Parveen S, Noohu MM. Effects of Neural Mobilization in Diabetic Peripheral Neuropathy: A Scoping Review. J Chiropr Med. 2023 Dec;22(4):313-321. doi: 10.1016/j.jcm.2023.10.002. Epub 2023 Nov 18.

  PMID: 38205228 BACKGROUND

• Alshimy, A. M., Ibrahim, S. M., Osama, L., & Metwally, H. M. (2023). Effect of neurodynamic mobilization techniques in patients with diabetic neuropathy. Human Movement, 24(3), 115-120.

  BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09